Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction
A Single Center Randomized Prospective Study on the Peristaltic Direction of Gastrointestinal Anastomosis in Roux-en-Y Reconstruction After Distal Curative Gastrectomy for Gastric Cancer
1 other identifier
interventional
148
1 country
1
Brief Summary
The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedStudy Start
First participant enrolled
April 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedMarch 22, 2022
March 1, 2022
2 years
March 10, 2021
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Early postoperative recovery results
Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.)
Within 1 month after surgery
Late postoperative recovery results
Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.)
1 year after surgery
Other Outcomes (1)
Postoperative complications
Within 1 month after surgery
Study Arms (2)
Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group
EXPERIMENTALThe isoperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was consistent.
Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group
ACTIVE COMPARATORThe antiperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.
Interventions
In this study, intervention methods include two kind directions of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer. One is the isoperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. The other is the antiperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.
Eligibility Criteria
You may qualify if:
- \) Pathological examination confirmation the adenocarcinoma of stomach before surgery
- \) Physical conditions compliance with the requirements for curative gastrectomy
- \) Consent to undergo the D2 lymphadenectomy, and the dissected proportion of stomach no less than 2/3
- \) Comply with the protocol during the whole study period
- \) No neoadjuvant therapy administration
- \) Sign informed consent and permission of withdraw in the whole study period
- \) Consent to provide the tissue specimens after surgery for this study
- \) Estimation the overall survival after surgery no less than 6 months
- \) No anesthesia or operation contraindication disease
- \) cT1-4N0-2M0 stage demonstration by CT and endoscopic ultrasonography examinations
- \) Negative cytological detection in operation
- \) No seriously concomitance's diseases
- \) Karnofsky Performance Scores (KPS) more than 60
- \) Examined lymph node count no less than 16
You may not qualify if:
- \) Women during pregnant stage and breast-feed stage
- \) Women of childbearing age without any contraceptive measures
- \) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
- \) Immunosuppressive therapists for organ transplantation
- \) Seriously uncontrolled recurrent infection
- \) other malignant tumors
- \) No abilities of self-knowledge or mental disorders
- \) Participating in other clinical trials
- \) Siewert I and II esophagogastric junction tumors
- \) Serious internal diseases obstruction surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital of Tianjin Medical University
Tianjin, 300060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 17, 2021
Study Start
April 2, 2021
Primary Completion
March 31, 2023
Study Completion
March 31, 2024
Last Updated
March 22, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share